Oral Nutritional Supplementation in Children

Children Clinical Trial

Official title:

Oral Nutritional Supplementation in Children With Picky Eating Behaviors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02125123
• Other study ID #: AL15
• Status: Terminated
• Phase: N/A
• First received: April 24, 2014
• Last updated: July 24, 2015
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 109 Months

Eligibility

Inclusion Criteria:

1. = 36 months and < 109 months of age.

2. Healthy and not suffering from any physical disability.

3. Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.

4. Capable of oral feeding.

5. Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).

6. Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

Exclusion Criteria:

1. History of an acute or chronic condition that may affect feeding habits or nutritional status.

2. Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.

3. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.

4. Any acute/chronic condition requiring medical treatment which may include hospitalization.

5. Allergy or intolerance to any ingredient in the study product.

6. Gastrointestinal infection, acute constipation or acute diarrhea.

7. Hepatitis B or C, or HIV, or malignancy.

8. Congenital cardiac defects.

9. Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.

10. Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Children

Intervention

Other:
• Nutritional Supplement and Counseling
Ready-to-feed nutritional supplement and dietary counseling
• Counseling
Dietary counseling

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D Intake		Change from Baseline to Week 4	No
Secondary	Macronutrient Intake	24-hour dietary recall interview	Change from Baseline to Week 4	No
Secondary	Micronutrient Intake	24-hour dietary recall interview	Change from Baseline to Week 4	No